Aprovações FDA PMA

Unknown Device

Requerente Abbott Molecular

Número PMA P030052

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Requerente Abbott Molecular, Inc.

Número PMA P110012

Classe 3

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

Requerente Abbott Molecular, Inc.

Número PMA P150041

Classe 3

Vagus nerve stimulator for rheumatoid arthritis

Requerente SetPoint Medical

Número PMA P240039

Classe 3

Daily wear soft contact lens to reduce the progression of myopia

Requerente CooperVision, Inc.

Número PMA P180035

Classe 3

replacement Heart-valve

Requerente Medtronic, Inc.

Número PMA P980043

Classe 3

heart-valve, non-allograft tissue

Requerente Medtronic, Inc.

Número PMA P970031

Classe 3

Device, thermal ablation, endometrial

Requerente Axora Medical, Inc.

Número PMA P140013

Classe 3

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Requerente Abbott Laboratories

Número PMA P980007

Classe 3

Device, incontinence, mechanical/hydraulic

Requerente Uromedica, Inc.

Número PMA P130018

Classe 3

Drug eluting permanent left ventricular (lv) pacemaker electrode

Requerente Medtronic, Inc.

Número PMA P060039

Classe 3

Lens, contact, orthokeratology, overnight

Requerente Contamac, Ltd.

Número PMA P240045

Classe 3